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歌礼制药-B:减重不减肌药研发推进顺利,市场空间广阔
国元国际控股· 2024-12-13 10:06
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歌礼制药(01672) - 2024 - 中期财报
2024-09-27 09:00
Financial Performance - Total revenue for the six months ended June 30, 2024, was zero, a decrease of 100% from RMB 46.5 million in the same period of 2023, primarily due to reduced market demand for Ritonavir products following effective control of COVID-19 in mainland China [3]. - The total revenue decreased by 59.7% to approximately RMB 49.0 million for the six months ended June 30, 2024, from approximately RMB 121.5 million in the same period of 2023 [5]. - Total revenue for the period was RMB 49,004,000, down from RMB 75,041,000 in the previous year, indicating a decline of about 34.7% [86]. - The company reported a total comprehensive loss of RMB 121,630,000 for the period, compared to a total comprehensive income of RMB 37,253,000 in the previous year [88]. - The company reported a loss attributable to ordinary equity shareholders of RMB 130,318,000 for the six months ended June 30, 2024, compared to a loss of RMB 16,559,000 for the same period in 2023 [111]. Research and Development - Research and development expenses increased by 43.5% to approximately RMB 132.4 million for the six months ended June 30, 2024, compared to RMB 92.3 million for the same period in 2023 [5]. - The company announced positive interim results from the Phase II clinical trial of ASC41 for treating NASH patients confirmed by liver biopsy [5]. - ASC40's Phase IIb FASCINATE-2 clinical trial for treating NASH also reported positive topline results, indicating progress in metabolic disease treatment [5]. - The company has made significant advancements in internal drug discovery for metabolic diseases during the reporting period [5]. - The company is focusing on ten key clinical stage assets targeting viral diseases, metabolic diseases, and tumors [25]. Cash and Liquidity - Cash and cash equivalents, along with other liquid assets, amounted to approximately RMB 2,117.2 million as of June 30, 2024, compared to RMB 2,516.4 million as of June 30, 2023, expected to support R&D activities until 2028 [5]. - As of June 30, 2024, the company had cash and cash equivalents of approximately RMB 2,117.2 million, sufficient to support R&D activities until 2028 [26]. - The company's cash and cash equivalents stood at RMB 342,994,000 as of June 30, 2024, compared to RMB 330,117,000 at the end of 2023, showing a slight increase of about 3.6% [89]. Clinical Trials and Product Development - ASC22 for chronic hepatitis B has shown a significant HBsAg decline with 21.1% (4 out of 19) of patients achieving HBsAg clearance after 24 weeks of treatment [12]. - ASC10, an oral prodrug for RSV, has demonstrated an EC50 of 0.51 to 0.6 µM against two clinical strains in vitro, indicating strong efficacy [13]. - ASC40, an oral small molecule targeting FASN for NASH, has received fast track designation from the US FDA [9]. - The Phase III trial for ASC40 in rGBM has completed patient enrollment, targeting approximately 180 patients for progression-free survival analysis [18]. - The company plans to submit Phase II data for ASC40 in 2024 and discuss registration trials with regulatory authorities [16]. Shareholder and Corporate Governance - The company’s chairman and CEO positions are held by the same individual, which the board believes enhances efficiency [65]. - The company confirmed compliance with corporate governance codes during the reporting period [65]. - The company did not recommend the payment of an interim dividend for the six months ending June 30, 2024 [79]. - The independent auditor, KPMG, reviewed the interim financial information and found it compliant with applicable accounting standards [78]. Employee and Management Costs - The total employee cost for the six months ended June 30, 2024, was approximately RMB 76.8 million, an increase from RMB 55.3 million for the same period in 2023, primarily due to payments made to R&D personnel [61]. - Total remuneration for key management personnel for the six months ended June 30, 2024, was RMB 44,544,000, significantly up from RMB 14,842,000 in the same period last year [130]. Legal and Regulatory Matters - The company has ongoing litigation with Viking Therapeutics regarding candidate drugs ASC41 and ASC43F, with no provisions made as of June 30, 2024 [128]. - The company incurred litigation expenses of RMB 20,459,000 for the six months ended June 30, 2024, compared to RMB 6,013,000 for the same period in 2023 [108]. Future Outlook and Strategy - The company plans to enhance its digital marketing strategies, aiming for a 20% increase in online engagement by the end of 2024 [135]. - The company is expanding its market presence in the Greater China region, targeting a market share increase of CC% by the end of 2024 [133]. - The company has established partnerships with leading research institutions to accelerate the development of its pipeline products [134].
歌礼制药-B:创新药研发推进顺利,BD合作空间广阔
国元国际控股· 2024-09-03 03:40
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歌礼制药(01672) - 2024 Q2 - 业绩电话会
2024-09-02 03:00
Financial Data and Key Metrics - The company's cash reserves as of June 30, 2024, exceeded RMB 2.1 billion, ensuring healthy operations and development for the next five years [1][2] - The company reported a loss of RMB 130 million in the first half of 2024, primarily due to increased R&D investments [1][2] - R&D personnel now account for 69% of the company's total workforce, reflecting a significant increase in R&D focus and efficiency [1][2] Business Line Data and Key Metrics - The company has focused on global BIC (Best-in-Class) and FIC (First-in-Class) pipeline development, particularly in metabolic diseases and oncology [1][2] - Key pipeline highlights include AAC40, which has successfully initiated Phase III trials, and AAC41, which showed promising Phase II results with 93.3% of patients achieving a 30% reduction in liver fat content [1][2] - The company has accelerated the development of global FIC and BIC candidates for metabolic diseases, with plans to continue this focus in the second half of 2024 [1][2] Market Data and Key Metrics - The company has engaged in extensive business development activities, including participation in major industry conferences such as the JP Morgan Healthcare Conference and the BioInnovation Biotechnology Innovation Organization's global PG conference [1][2] - A top-ten global chemical company expressed interest in the company's pipeline, selecting only 70 out of 1,000 biotech companies for meetings, with the company being one of the selected [1][2] Company Strategy and Industry Competition - The company's strategy is centered on global BIC and FIC pipeline development, avoiding "Me Too" drugs and focusing on top-tier competitive targets [1][2] - The company has increased its patent filings, with four new drug invention patents granted and 51 new applications filed in the first half of 2024, strengthening its competitive position [1][2] - The company plans to continue accelerating the development of global FIC and BIC candidates, particularly in metabolic diseases, to maintain its competitive edge [1][2] Management Commentary on Operating Environment and Future Outlook - Management emphasized the importance of healthy survival in a challenging industry environment, focusing on global BIC and FIC pipeline development and business development activities [1][2] - The company expects to complete key clinical milestones in the second half of 2024, including Phase III enrollment for AAC40 and Phase II completion for AAC41, with top-line data expected in the first half of 2025 [1][2] - Management expressed confidence in the company's cash reserves and R&D capabilities, aiming to maximize the value of its core pipelines before engaging in further business development activities [1][2] Other Important Information - The company has initiated a stock repurchase program, having already repurchased RMB 133 million worth of shares, with plans to continue repurchasing if cash reserves allow [1][2] - The company is exploring the potential of its AAC61 small molecule PD-L1 oral inhibitor, seeking potential partners following promising Phase I results [1][2] Summary of Q&A Session Question: What were the main projects driving the increase in R&D expenses in the first half of 2024? - The increase in R&D expenses was primarily driven by Phase III trials for AAC40, Phase II trials for AAC41, and the acceleration of global FIC and BIC candidate development for metabolic diseases [1][2] Question: When will the efficacy data for AAC40's Phase III trials be available? - Efficacy data for AAC40's Phase III trials is expected to be available in the first half of 2025, with safety follow-up data not impacting the efficacy data readout [1][2] Question: Is the company still working on the AS110 monkeypox project? - The company is conducting further internal evaluations of the AS110 monkeypox project, given the recent rise in monkeypox cases [1][2] Question: How does the company view the competition between its two NASH drugs and weight-loss drugs? - The company's NASH drugs (AAC40 and AAC41) are oral medications targeting liver fat reduction, while weight-loss drugs like GLP-1 are injectable and focus on weight management, indicating different market segments [1][2] Question: Will the company continue its stock repurchase program? - The company will prioritize R&D investments but may continue stock repurchases if cash reserves allow, with a focus on maintaining healthy operations and development [1][2] Question: When will the company form a commercialization team? - The company will consider forming a commercialization team once its pipelines receive regulatory approval, with a focus on global markets rather than domestic sales [1][2] Question: What are the company's future early-stage R&D pipeline plans? - The company's early-stage R&D pipeline will continue to focus on metabolic diseases, building on its current pipeline of AAC40 and AAC41 [1][2]
歌礼制药(01672) - 2024 - 中期业绩
2024-08-30 09:00
Financial Performance - For the six months ended June 30, 2024, the company reported no revenue, a decrease of 100% compared to RMB 46,506 thousand for the same period in 2023[2]. - The net loss for the period increased by 687.0% to approximately RMB 130,318 thousand for the six months ended June 30, 2024, compared to RMB 16,559 thousand for the same period in 2023[4]. - Basic and diluted loss per share increased by 743.4% to RMB (12.82) for the six months ended June 30, 2024, compared to RMB (1.52) for the same period in 2023[2]. - Other income and gains decreased by 34.7% to approximately RMB 49,004 thousand for the six months ended June 30, 2024, compared to RMB 75,041 thousand for the same period in 2023[2]. - The group reported a total loss of RMB 130.3 million, compared to a loss of RMB 16.6 million for the same period in 2023[54]. - The group’s basic and diluted loss per share for the six months ended June 30, 2024, was RMB (12.82) cents, compared to RMB (1.52) cents in the previous year[54]. Research and Development - The company's R&D expenses increased by 43.5% to approximately RMB 132,382 thousand for the six months ended June 30, 2024, compared to RMB 92,258 thousand for the same period in 2023[4]. - The company is focused on addressing unmet medical needs in viral diseases, metabolic diseases, and oncology[3]. - The company has made significant progress in internal drug discovery for metabolic diseases[5]. - ASC40, an oral small molecule for NASH, has received fast track designation from the FDA in the United States[7]. - The company aims to accelerate the development of global best-in-class candidates for metabolic diseases and enhance its global competitiveness[22]. - The company is exploring various licensing opportunities for its clinical and preclinical assets[22]. - The company plans to establish strategic decisions for ASC22's functional cure for HIV in 2024[13]. - The company plans to establish a strategic decision for ASC10 and ASC11 regarding COVID-19 treatment in 2024[14]. - The company is actively engaged in the development of therapies for recurrent glioblastoma (rGBM), showcasing its commitment to addressing critical health issues[87]. Clinical Trials and Drug Development - The company announced positive interim results for the Phase II clinical trial of ASC41 for treating NASH patients[5]. - ASC22 for chronic hepatitis B achieved a significant HBsAg clearance rate of 21.1% (4 out of 19 patients) after 24 weeks of treatment[10]. - ASC10, an oral prodrug, demonstrated an EC50 of 0.51 to 0.6 µM against RSV in vitro, indicating strong antiviral activity[11]. - The company has received FDA and NMPA approvals to initiate Phase IIa clinical trials for ASC10 targeting RSV infections[11]. - The ASC40 trial for NASH is expected to submit Phase IIb data to the FDA in 2024 and discuss registration trials with the National Medical Products Administration[14]. - The ASC41 trial is set to complete patient enrollment for its Phase II clinical study in 2024[15]. - The ASC40 trial for rGBM has completed patient enrollment, with approximately 180 patients participating in a study assessing progression-free survival and overall survival[16]. - The ASC61 trial for advanced solid tumors has completed patient enrollment in its Phase I clinical trial[17]. - The ASC40 treatment group in the NASH trial had a statistically significant reduction in ALT and AST levels, with reductions of 37.8% and 41.5% respectively after 12 weeks[15]. - The ASC40 trial for rGBM will conduct a mid-term analysis after observing 93 progression-free survival events[16]. Financial Position and Cash Flow - The company had cash and cash equivalents of approximately RMB 2,117.2 million as of June 30, 2024, down from RMB 2,516.4 million as of June 30, 2023[4]. - As of June 30, 2024, the company had no borrowings or outstanding debts, including mortgages, bonds, or bank overdrafts[49]. - The net cash flow used in operating activities was approximately RMB 203.4 million, primarily due to an operating loss of about RMB 149.1 million before changes in working capital[45]. - The net cash flow from investing activities for the same period was approximately RMB 261.6 million, mainly due to the redemption of fixed deposits maturing in over three months amounting to about RMB 243.0 million[46]. - The net cash flow used in financing activities was approximately RMB 45.5 million, primarily related to share repurchases during the reporting period[47]. - The current ratio increased from 16.6 as of December 31, 2023, to 24.4 as of June 30, 2024, while the quick ratio rose from 16.5 to 24.3, primarily due to a decrease in current liabilities[50]. Employee and Corporate Governance - As of June 30, 2024, the group had a total of 219 employees, with 217 located in China, and over 79.5% holding a bachelor's degree or higher[52]. - The total employee cost for the six months ended June 30, 2024, was approximately RMB 76.8 million, an increase from RMB 55.3 million for the same period in 2023, primarily due to R&D personnel compensation[52]. - The company continues to recruit employees through various channels, including recruitment websites and job fairs, and provides training for new hires[52]. - The company maintains high standards of corporate governance and has adopted a code of conduct for securities trading, with all directors confirming compliance during the reporting period[77][78]. Market and Strategic Outlook - The global RSV drug market is projected to grow at a CAGR of 14.9%, reaching $4.2 billion by 2027[11]. - The estimated global population of HIV carriers in 2022 was approximately 39 million, with around 630,000 deaths related to AIDS[13]. - The company is exploring market expansion opportunities, particularly in the United States, to enhance its competitive position[87]. - The strategic emphasis on partnerships and collaborations may lead to potential mergers and acquisitions in the future[87].
歌礼制药(01672) - 2023 - 年度财报
2024-04-26 08:49
Clinical Trials and Development - ASC40 achieved significant efficacy and safety in the Phase II clinical trial for acne, with a mechanism that directly inhibits sebum production and inflammation[3]. - ASC40's Phase III clinical trial for acne is set to complete patient enrollment in 2024, targeting 480 moderate to severe acne patients[20]. - ASC42 demonstrated a 1,780% increase in the biomarker FGF19 and a 91% decrease in C4 levels after 14 days of treatment at a dose of 15 mg once daily[2]. - The company plans to complete patient enrollment for the Phase II clinical trial of ASC41 for NASH in 2024[9]. - The Phase III registration study for ASC40 in rGBM has enrolled 120 patients, with a planned total of 180 patients[13]. - ASC61, a potent oral PD-L1 inhibitor, is currently in a Phase I dose-escalation trial for advanced solid tumors in the U.S.[17]. - The company completed the enrollment of 120 patients in the Phase III clinical trial of ASC40 for rGBM treatment[30]. - The company made a strategic decision to discontinue the ASC42 clinical trial for PBC based on the efficacy and safety data from the Phase II study[39]. - ASC43F, a fixed-dose combination of 5 mg THRβ agonist ASC41 and 15 mg FXR agonist ASC42, demonstrated good safety and tolerability in a Phase I clinical trial with no clinically significant adverse events reported[40]. - ASC22, an immune therapy for functional cure of chronic hepatitis B, is progressing rapidly in clinical development, targeting a significant unmet medical need with approximately 86 million people infected in China[61]. - The company aims to submit Phase II data for ASC40 in the treatment of moderate to severe fibrosis (F2 or F3) NASH patients in the U.S. in 2024[102]. - The company is conducting a Phase II clinical trial for ASC41 in confirmed NASH patients, with interim results expected to be announced on January 2, 2024[103]. - The company is exploring further clinical development opportunities for ASC22 in combination with other drugs for the functional cure of chronic hepatitis B[93]. - The company achieved positive topline results in the 52-week Phase IIb FASCINATE-2 clinical trial for ASC40 in patients with confirmed fibrosis stages 2 or 3 NASH[101]. - The ASC22 trial included 49 patients with baseline HBsAg ≤ 100 IU/mL, treated with 1.0 mg/kg of ASC22 or placebo every two weeks for 24 weeks[195]. - ASC22 combined with vedolizumab showed good tolerability and effectively activated latent HIV reservoirs in a Phase II study with significant increases in CA HIV RNA observed[67]. Financial Performance - The company's total revenue increased by 4.6% from approximately RMB 541 million for the year ended December 31, 2022, to approximately RMB 566 million for the year ended December 31, 2023[27]. - Other income and gains rose by 64.8% from approximately RMB 112 million for the year ended December 31, 2022, to approximately RMB 185 million for the year ended December 31, 2023[27]. - The company's total revenue, including both revenue and other income and gains, increased by 45.2% from approximately RMB 661 million for the year ended December 31, 2022, to approximately RMB 1,241 million for the year ended December 31, 2023[27]. - Gross profit for the year ended December 31, 2023, was approximately RMB 26 million, compared to a gross loss of approximately RMB 25 million for the year ended December 31, 2022[28]. - The company recorded a net loss of approximately RMB 145 million for the year ended December 31, 2023, compared to a net loss of approximately RMB 315 million for the year ended December 31, 2022[26]. - The net loss margin for the year ended December 31, 2023, was (255.7)%, compared to (582.1)% for the year ended December 31, 2022[26]. - The company's administrative expenses rose by 228.5% to approximately RMB 115.6 million for the year ended December 31, 2023, from approximately RMB 35.2 million for the year ended December 31, 2022, mainly due to increased consulting fees and employee-related costs[119]. - The company's annual loss decreased from RMB 314.8 million for the year ended December 31, 2022, to RMB 144.7 million for the year ended December 31, 2023, primarily due to increased product sales revenue and improved inventory management[187]. - The company reported a significant reduction in other expenses from approximately RMB 59.8 million for the year ended December 31, 2022, to approximately RMB 2.1 million for the year ended December 31, 2023, mainly due to a decrease in impairment of other intangible assets[149]. - The company's financing costs were approximately RMB 0.1 million for the year ended December 31, 2023, down from RMB 0.2 million for the year ended December 31, 2022, due to interest on lease liabilities[150]. Research and Development - The company has established a pipeline of 12 key clinical stage assets focusing on viral diseases, NASH, and tumors[9]. - The company aims to enhance its global competitiveness by accelerating the development of innovative or best-in-class candidates[9]. - The company is focusing on expanding its product pipeline in viral diseases and oncology, with several candidates in various clinical trial phases[190][192]. - The company is developing multiple products targeting NASH and PBC, including ASC40, ASC41, ASC42, and ASC43F, with global rights for most products[190]. - ASC40, a combination of FASN and VEGF, is aimed at treating recurrent glioblastoma in the Greater China region[192]. - ASC61 targets PD-L1 for late-stage solid tumors and is in the global development stage[192]. - The company is advancing the ASC10 and ASC11 programs for COVID-19 and RSV, respectively, with ongoing clinical evaluations[109]. Sustainability and Corporate Strategy - The company has implemented several initiatives to reduce its carbon footprint, reflecting its commitment to sustainability[24]. - The company is seeking opportunities to license multiple clinical assets[8]. - The company is exploring various licensing opportunities for preclinical and clinical stage assets to optimize resource strategy[78]. - The company aims to leverage its innovative therapies to address unmet medical needs in chronic hepatitis B and cancer[195]. - The company plans to complete a comprehensive data analysis of the ASC22 combined ART Phase II study in 2024 to inform strategic decisions[84]. - The company has obtained exclusive rights for ASC40 in the Greater China region from Sagimet Biosciences[56]. - The company has received six IND approvals from the FDA and/or the National Medical Products Administration, supporting four candidates in ongoing Phase II or III clinical trials[108]. Inventory and Receivables Management - The company's inventory decreased from approximately RMB 20.5 million as of December 31, 2022, to approximately RMB 6.1 million as of December 31, 2023, primarily due to a decline in sales of COVID-19 products leading to impairment of Ritonavir products[126]. - Trade receivables decreased significantly from approximately RMB 23.9 million as of December 31, 2022, to approximately RMB 5.4 million as of December 31, 2023[128]. - The company's deductible VAT input tax increased by 164.4% from approximately RMB 5.4 million as of December 31, 2022, to approximately RMB 14.3 million as of December 31, 2023, mainly due to a decrease in VAT refunds[158]. - Trade receivables decreased from approximately RMB 23.9 million as of December 31, 2022, to approximately RMB 5.4 million as of December 31, 2023, primarily due to the cessation of promotional services for Palosim in China[162]. - The company's prepaid expenses decreased by 49.2% from approximately RMB 8.1 million as of December 31, 2022, to approximately RMB 4.1 million as of December 31, 2023, due to reduced R&D-related prepayments[164].
创新药研发取得优异成果,现金储备充足
国元国际控股· 2024-03-26 16:00
Investment Rating - The report suggests a positive investment outlook for the company, indicating that it is significantly undervalued with a market capitalization of only HKD 1.5 billion [6]. Core Insights - The company has achieved excellent results in innovative drug development, with a strong cash reserve of RMB 2.275 billion, sufficient to support research and development until 2028 [6]. - In 2023, the company reported a revenue increase of 4.6% to RMB 56.6 million, with a substantial reduction in losses from RMB 315 million in 2022 to RMB 145 million in 2023, primarily driven by increased sales from the Ritonavir product [6]. - The company is focused on key pipeline developments, including six Phase II or III clinical trials across various disease areas such as acne, hepatitis B, NASH, and glioblastoma [6]. Revenue and Loss Analysis - The 2023 revenue of RMB 56.6 million reflects a 4.6% increase, attributed to higher product sales, improved inventory management leading to lower sales costs, and increased other income from bank interest and equity gains from Sagimet Biosciences' IPO [6]. - The significant narrowing of losses is a positive indicator of the company's financial health and operational efficiency [6]. Clinical Pipeline Progress - The ASC40 product for acne treatment has shown promising Phase II clinical trial results, with a 53.1% reduction in total lesions at the 25 mg dose and a 61.3% reduction at the 50 mg dose, demonstrating statistical significance and good safety [6]. - The company is actively pursuing international business development projects, particularly for the ASC40 acne project, which has a vast market potential [6]. Strategic Focus - The company is a research-driven biotech firm, making significant progress in the development of ASC40 for acne, NASH, and glioblastoma, while also advancing global collaborations [6]. - The report emphasizes the company's commitment to investor returns, having repurchased and canceled HKD 130 million worth of shares, indicating a focus on enhancing shareholder value [6].
歌礼制药(01672) - 2023 - 年度业绩
2024-03-25 13:00
Financial Performance - Gross profit for the year ended December 31, 2023, was approximately RMB 26.0 million, compared to a gross loss of RMB 24.7 million in 2022, driven by improved cost control and a revenue increase of approximately RMB 2.5 million, or 4.6% [30]. - Total revenue increased by 4.6% from approximately RMB 541 million in 2022 to approximately RMB 566 million in 2023, primarily due to an increase in revenue from Ritonavir products of approximately RMB 494 million, offset by a decrease in promotional service revenue of approximately RMB 404 million [43]. - The group’s revenue increased by 4.6% from approximately RMB 541 million for the year ended December 31, 2022, to approximately RMB 566 million for the year ended December 31, 2023 [61]. - Other income and gains increased by 64.8% from approximately RMB 112.0 million in 2022 to about RMB 184.7 million in 2023, largely due to gains from an IPO and increased bank interest income [32]. - The company reported a pre-tax loss of approximately RMB 144.7 million in 2023, a significant improvement from a loss of approximately RMB 314.8 million in 2022 [59]. - The annual loss reduced from RMB 3,148 million for the year ended December 31, 2022, to RMB 1,447 million for the year ended December 31, 2023 [84]. Research and Development - The company's R&D costs for the year ended December 31, 2023, totaled approximately RMB 216.8 million, a decrease from RMB 267.1 million in 2022, primarily due to reduced clinical expenses [20]. - R&D costs decreased by 18.8% from approximately RMB 671 million in 2022 to approximately RMB 668 million in 2023, attributed to improved efficiency in clinical and preclinical projects and reduced depreciation and amortization costs [45]. - The company has established 12 key clinical stage assets focusing on viral diseases, NASH, and tumors, with strategic goals for 2024 including completing patient enrollment for ASC41 in NASH Phase II trials and initiating discussions with the National Medical Products Administration for ASC40 registration trials [41]. - ASC40 for moderate to severe acne has entered Phase III clinical trials, with 480 subjects randomized to receive either ASC40 or a placebo for 12 weeks [51]. - ASC61, an oral PD-L1 small molecule inhibitor, is currently undergoing Phase I clinical trials in the U.S. for advanced solid tumors, with a focus on determining the recommended dose for Phase II trials [49]. - The group achieved six IND approvals from the FDA and/or national drug regulatory authorities, supporting four candidates in ongoing Phase II or III clinical trials [62]. Expenses and Cost Management - Administrative expenses rose by 228.5% to approximately RMB 115.6 million in 2023, primarily due to increased consulting fees and employee-related costs [35]. - Sales and distribution expenses decreased by 97.7% to approximately RMB 0.4 million in 2023, attributed to the cessation of promotional activities for a specific product [34]. - The total administrative expenses composition showed that agency and consulting fees accounted for 54.0% of the total in 2023, compared to only 11.7% in 2022 [37]. - Other expenses significantly decreased by 96.4% from approximately RMB 59.8 million for the year ended December 31, 2022, to approximately RMB 2.1 million for the year ended December 31, 2023, primarily due to a reduction in impairment of other intangible assets [152]. Cash Flow and Liquidity - Cash and cash equivalents, along with time deposits, amounted to approximately RMB 2,274.6 million, expected to support R&D activities and operations until 2028 [55]. - The net cash flow used in operating activities for the year ended December 31, 2023, was approximately RMB 144.2 million, mainly due to an operating loss of approximately RMB 258.2 million before changes in working capital [165]. - The company reported a net cash flow used in financing activities of approximately RMB 81.5 million for the year ended December 31, 2023, primarily due to share repurchases during the reporting period [167]. - The company’s cash and cash equivalents decreased from RMB 2,470.834 million as of December 31, 2022, to RMB 2,274.574 million as of December 31, 2023 [180]. Clinical Trials and Product Development - The company anticipates completing patient enrollment for the Phase III clinical trial of ASC40 for acne in 2024 [27]. - The group completed the enrollment of 120 patients in the Phase III registration trial of ASC40 for rGBM treatment, which may allow for a mid-term analysis [85]. - The ongoing phase II study of ASC22 for HIV-1 is evaluating safety and efficacy with a treatment period of 12 weeks [98]. - The ASC40 clinical trial for NASH is a 52-week study involving 168 patients with confirmed fibrosis, aiming to submit phase 2b data to the FDA in 2024 [104]. - ASC10, an oral prodrug, has shown effective inhibition of respiratory syncytial virus with an EC50 of 0.51 to 0.6 µM in preclinical studies [118]. Market and Strategic Outlook - The global RSV drug market is projected to grow at a compound annual growth rate (CAGR) of 14.9%, reaching $4.2 billion by 2027 [95]. - The company aims to enhance global competitiveness by accelerating the development of first-in-class or best-in-class drug candidates [41]. - The company is actively seeking opportunities for out-licensing several clinical assets [40]. - The company is exploring further clinical development opportunities for ASC22 in combination with other therapies for chronic hepatitis B functional cure [116].
歌礼制药(01672) - 2023 - 中期财报
2023-09-27 08:01
Financial Performance - Total revenue increased by 21.7% to approximately RMB 46.5 million for the six months ended June 30, 2023, compared to RMB 38.2 million for the same period in 2022[16]. - Gross profit rose by 58.5% to RMB 38.6 million, up from RMB 24.4 million year-on-year[13]. - Other income and gains increased by 56.9% to RMB 75.0 million, compared to RMB 47.8 million in the previous year[16]. - The company reported a pre-tax loss of RMB 16.6 million, significantly reduced from RMB 88.0 million in the previous year, reflecting an 81.2% improvement[13]. - The net loss margin improved to (35.6%) from (230.3%) year-on-year[13]. - The total comprehensive income for the period was RMB 37,253,000, compared to a loss of RMB 18,781,000 in the previous year[118]. - The company reported a loss attributable to equity holders of RMB 16,559,000 for the six months ended June 30, 2023, compared to a loss of RMB 87,998,000 in the same period of 2022, showing an improvement in financial performance[164]. Research and Development - The company achieved five IND approvals from the US FDA and China's National Medical Products Administration during the reporting period[17]. - The company plans to initiate a Phase III clinical trial for ASC40, a treatment for acne, in the second half of 2023[36]. - ASC42, a new selective non-steroidal FXR agonist, is undergoing a Phase II study with 98 patients, targeting those who are intolerant or unresponsive to UDCA[38]. - The ASC40 clinical trial for rGBM has enrolled 108 patients out of a planned 180, with an objective response rate of 56% reported in previous studies[181]. - ASC43F has shown good safety and tolerability in Phase I clinical trials, with significant reductions in LDL-C and triglycerides in overweight and obese subjects[177]. - The company plans to complete the enrollment of approximately 120 rGBM patients for interim analysis by the third quarter of 2023[182]. - ASC61 is currently undergoing Phase I clinical trials for advanced solid tumors, with a focus on determining the recommended dose for Phase II trials[183]. - The company has optimized its resources to focus on 12 clinical-stage assets, most of which have the potential to be first-in-class or best-in-class products[196]. Cash and Liquidity - Cash and bank balances as of June 30, 2023, were approximately RMB 2,512.9 million, sufficient to support R&D activities and operations until 2027[16]. - Cash and cash equivalents, along with time deposits with maturities over three months, totaled RMB 2,512.9 million as of June 30, 2023, compared to RMB 2,470.8 million at the end of 2022[20]. - The total cash and cash equivalents increased to RMB 469.69 million as of June 30, 2023, from RMB 1,103.02 million at the end of June 30, 2022[31]. - The company reported a net cash flow from investing activities of RMB 141,685,000, a significant recovery from a net outflow of RMB 571,882,000 in the same period of 2022[136]. - The company’s total cash and cash equivalents at the end of the period stood at RMB 469,694,000, down from RMB 1,103,020,000 in the previous year[136]. Assets and Liabilities - As of June 30, 2023, the total assets of the company amounted to RMB 691,000, a decrease from RMB 6,267,000 as of December 31, 2022[40]. - Total liabilities decreased from RMB 108,189,000 to RMB 83,267,000, a reduction of about 23.1%[126]. - The company reported no borrowings as of June 30, 2023[41]. - The debt-to-asset ratio improved to 3.4% as of June 30, 2023, down from 4.4% as of December 31, 2022[46][47]. - Trade payables increased to RMB 6,953 million as of June 30, 2023, compared to RMB 3,135 million as of December 31, 2022, reflecting a significant growth[24]. - Other payables decreased to approximately RMB 40.4 million as of June 30, 2023, from approximately RMB 42.7 million as of December 31, 2022, indicating stability in liabilities[26]. Shareholder Information - As of June 30, 2023, the total number of shares issued by the company is 1,087,134,000[95]. - Dr. Wu holds 514,393,664 shares, representing 47.32% of the company's equity[81]. - Mrs. Wu holds 82,827,414 shares, representing 7.62% of the company's equity[81]. - Major shareholders include C-Bridge Capital GP, Ltd. and TF Capital, Ltd., each holding 64,154,727 shares, representing 5.90%[87]. - The company repurchased a total of 5,705,000 shares at a total cost of HKD 10,913,340 in June 2023[72]. - The company repurchased an additional 8,690,000 shares at a total cost of HKD 18,261,340 in July 2023[72]. Corporate Governance - The company maintained compliance with all applicable corporate governance codes during the reporting period[70]. - The company has adopted a written guideline for securities trading that meets or exceeds the standards of the code[71]. - The company did not grant any stock options to any directors during the reporting period[59]. - The company’s board believes that having the same person serve as both chairman and CEO enhances efficiency in leading and managing the company[70].
歌礼制药(01672) - 2023 Q2 - 业绩电话会
2023-09-07 02:40
欢迎各位投资者来到2023年中期录演季上市公司录演现场本次录演由智通财经与第一上海联合主办录演即将开始请各位投资者将手机调至静音下面有请哥里之耀进行录演及投资者交流时长40分钟有请哥里之耀谢谢智通财经和第一上海的组织 22%主要的收入贡献是立陶纳为我们从2022年的下半年陆续跟国内的几家大的做新冠口服药的公司都签订了相关的合同所以还是抓住这样一次性的机会但是因为新冠疫情已经过去所以我们不会对于新冠的业务或者它的收入有非常高的期望 上半年还有接近4000多万的理财的收益利息所以资金这块的公司在18A的这些公司当中看起来还是非常的充裕与此同时我们上半年也做了一些优化把之前的一些管线做了缩减目前就主力聚焦在刚刚提到的这些项目上上半年我们的研发费用是9200万全年预计可能也就是2亿多一点 我们在五月份也公布了桌窗的二期数据其实整个今年上半年公司的管线的进展还是非常的顺利与此同时我们也是从6月20号开始进行实时回购从6月15号以来到现在我们已经累计回购了接近4000万港币这也是在所有的18A公司当中为数不多的 重点推进的几个项目首先第一个是我们看一下在Nash领域Nash这块在国内来看颗粒是绝对的做得比较好的公司我们从 ...